A Prospective Study Based on Spatial Multi-omics to Predict the Efficacy of ADT Combined With Second-generation Novel Hormonal Agents in Metastatic Hormone-sensitive Prostate Cancer.

NCT07795177 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KY2026-09-81
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Keywords

Metastatic hormone-sensitive prostate cancer (mHSPC); Spatial multi-omics; ADT combined with androgen receptor pathway inhibitors (ADT+ARPI); Treatment response prediction model; Precision medicine / individualized therapy

Outcome Measures

Primary Outcomes (2)

• Biochemical Progression-Free Survival (bPFS)

  Time from initiation of ADT plus ARPI therapy to biochemical progression or death from any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to ≥0.2 ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2 weeks apart. Participants without an event will be censored at the date of last follow-up.

  From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (±1 month) for up to 24 months.

• Overall Survival (OS)

  Time from treatment initiation to death from any cause. Participants alive or lost to follow-up will be censored at the date last known alive.

  From treatment initiation until death or last follow-up, assessed up to 24 months.

Secondary Outcomes (4)

• Mutation Frequency of Key Genes Assessed by Whole-Exome Sequencing (WES)

  Baseline (at enrollment, from biopsy tissue).

• Spatial Gene Expression Signatures Measured by Xenium Platform

  Baseline (at enrollment).

• Spatial Protein Marker Expression Measured by PhenoCycler-Fusion (PCF)

  Baseline (at enrollment).

• Area Under the Receiver Operating Characteristic Curve (AUC) of the Multi-omics Prediction Model for 6-Month Undetectable PSA（ PSA <0.2 ng/mL ）

  Baseline data used to predict outcome at 6 months after treatment initiation.

Study Arms (1)

Newly diagnosed mHSPC patients who meet the inclusion criteria

EXPERIMENTAL

Eligible patients will be enrolled after providing written informed consent. Individualized therapy (ADT plus abiraterone or other ARPIs) will be prescribed by the investigators according to each patient's financial situation, drug availability, and clinical needs, with regular follow-ups performed following routine real-world practice

Drug: ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide)

Interventions

ADT plus abiraterone or other ARPIs（apalutamide, enzalutamide, rezvilutamide, darolutamide) DRUG

The spatial heterogeneity of the tumor microenvironment in mHSPC-encompassing immune cell infiltration patterns, tumor-stroma interface features, and the regional activation status of critical signaling pathways-is intimately linked to clinical outcomes with ADT plus ARPI therapy. Through comprehensive spatial multi-omic profiling, these spatial attributes can be systematically dissected to uncover pivotal predictive biomarkers, facilitate the development of accurate response prediction models, and ultimately guide personalized therapeutic strategies for patients with mHSPC

Also known as: ADT plus abiraterone, ADT plus Apalutamide, ADT plus Enzalutamide, ADT plus Darolutamide, ADT plus rezvilutamide

Newly diagnosed mHSPC patients who meet the inclusion criteria

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 85 years.
• Histopathologically confirmed prostate adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma.
• Imaging evidence of definite distant metastases (according to RECIST criteria).
• Pre-biopsy PSA ≥ 20 ng/mL or Gleason score ≥ 4+4.
• No prior hormonal therapy or other systemic anti-tumor regimens.
• ECOG performance status 0-2, with an estimated life expectancy \> 6 months.
• Adequate organ function.h. Ability and willingness to provide written informed consent, and capability to comply with the study visit schedule.

You may not qualify if:

• Histopathological diagnosis of neuroendocrine or small cell prostate cancer.
• No definite distant metastases detected on imaging.
• Prior history of anti-tumor therapy (including neoadjuvant, adjuvant, or other treatments).
• Submitted biopsy samples fail to meet quality control requirements.
• Concurrent severe endocrine or metabolic disorders, or other severe digestive system diseases.
• Concurrent chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, or other relevant conditions.
• History of immunodeficiency or organ transplantation.
• History of other concurrent malignancies.
• Concurrent enrollment in other clinical trials.
• Other conditions that the investigator deems unsuitable for study enrollment.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Universitythe First Affiliatedhospital of Anhuimedical

Hefei, Anhui, 230022, China

Location

Related Publications (21)

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MeSH Terms

Interventions

Androgen Antagonists; abiraterone; enzalutamide; darolutamide; apalutamide

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sheng Tai, M.D.

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Hongzhi Wang, M.D.

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Tai, M.D.

CONTACT

86-18355159268; Taishengwk@163.com

Hongzhi Wang, M.D.

CONTACT

86-18846156838; wanghongzhi0830@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the chief of the ward

Model Details: * Patient recruitment and enrollment (targeting approximately 40 patients). * Pre-treatment sample collection and spatial multi-omics profiling. * Patients receiving ADT combined with ARPI therapy. ④ Regular follow-up and collection of efficacy data. ⑤ Integration of spatial multi-omics data with clinical efficacy data. ⑥ Screening for spatial molecular biomarkers predictive of treatment response. ⑦ Construction and validation of a predictive efficacy model.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

CN (1)